A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma Summary The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma .
View Eligibility Criteria Eligibility Criteria Inclusion Criteria: Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age). Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system. Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent). Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition). Exclusion Criteria: Participants must not have ocular melanoma. Participants must not have a history of myocarditis, regardless of etiology. Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
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There are 92 Locations for this study
Dignity Health - St. Josephs Hospital and Medical Center Phoenix Arizona, 85013, United States
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Stanford Univ Med School Dept of Dermatology Stanford California, 94305, United States
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The Melanoma and Skin Cancer Institute Englewood Colorado, 80113, United States
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Ft. Wayne Medical Oncology and Hematology Fort Wayne Indiana, 46804, United States
Greenebaum Cancer Center University of Maryland Baltimore Maryland, 21201, United States
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Oncology Hematology West P.C. dba Nebraska Cancer Specialist Omaha Nebraska, 68130, United States
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Rutgers CINJ New Brunswick New Jersey, 08901, United States
Cleveland Clinic Cleveland Ohio, 44195, United States
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St. Lukes University Health Network Easton Pennsylvania, 18045, United States
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Thomas Jefferson University Hospital Philadelphia Pennsylvania, 19107, United States
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Intermountain Medical Center Campus Location Murray Utah, 84107, United States
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Local Institution - 0042 Caba Buenos Aires, 1125, Argentina
Local Institution - 0133 Ciudad Autonoma de Buenos Aires Buenos Aires, 1426, Argentina
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Local Institution - 0145 Caba Ciudad Autonoma De Buenos Aires, 1430, Argentina
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Local Institution - 0160 Rosario Santa Fe, 2000, Argentina
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Local Institution - 0067 Buenos Aires , C1121, Argentina
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Local Institution - 0172 Port Macquarie New South Wales, 2444, Australia
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Local Institution - 0118 Wagga Wagga New South Wales, 2650, Australia
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Local Institution - 0033 Westmead New South Wales, 2145, Australia
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Local Institution - 0008 Bendigo Victoria, 3550, Australia
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Local Institution - 0154 Heidelberg Victoria, 3084, Australia
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Local Institution - 0030 Prahran Victoria, 3004, Australia
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Local Institution - 0161 Nedlands Western Australia, 6009, Australia
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Local Institution - 0168 St. Poelten Lower Austria, 3100, Austria
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Local Institution - 0027 Graz , 8036, Austria
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Local Institution - 0078 Charleroi Hainaut, 6000, Belgium
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Local Institution - 0147 Curitiba Parana, 80520, Brazil
Local Institution - 0025 Ijui Rio Grande Do Sul, 98700, Brazil
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Local Institution - 0132 Florianopolis Santa Catarina, 88034, Brazil
Local Institution - 0018 Sao Jose do Rio Preto Sao Paulo, 15090, Brazil
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Local Institution - 0159 Blumenau SC, 89010, Brazil
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Local Institution - 0130 Sao Paulo , 01321, Brazil
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Local Institution - 0141 Calgary Alberta, T2N 4, Canada
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Local Institution - 0121 Hamilton Ontario, L8V 5, Canada
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Local Institution - 0143 Temuco Araucania, 48008, Chile
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Local Institution - 0140 Recoleta Metropolitana, 83804, Chile
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Local Institution - 0144 Santiago Metropolitana, 01010, Chile
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Local Institution - 0142 Vitacura Metropolitana, JC5G , Chile
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Local Institution - 0119 Santiago de Chile Providencia, 75006, Chile
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Local Institution - 0152 Bogota , 11151, Colombia
Local Institution - 0149 Medellin , 50030, Colombia
Local Institution - 0150 Valledupar , 20000, Colombia
Local Institution - 0164 Helsinki , 00029, Finland
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Local Institution - 0167 Tampere , 33521, Finland
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Local Institution - 0162 Turku , 20521, Finland
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Local Institution - 0108 Toulouse Haute Garonne, 31059, France
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Local Institution - 0034 Paris Ile De France, 75475, France
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Local Institution - 0127 Chambray-les-Tours Indre-Et-Loire, 37044, France
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Local Institution - 0111 Lille Nord, 59000, France
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Local Institution - 0061 Villejuif Cedex Val-De-Marne, 94805, France
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Local Institution - 0007 Amiens , 80054, France
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Local Institution - 0128 Bayonne , 64100, France
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Local Institution - 0129 Clermont Ferrand , 63003, France
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Local Institution - 0046 Dijon , 21000, France
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Local Institution - 0052 Pierre-Benite , 69310, France
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Local Institution - 0101 Heidelberg Baden-Württemberg, 69120, Germany
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Local Institution - 0079 Ulm Baden-Württemberg, 89081, Germany
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Local Institution - 0011 Regensburg Bayern, 93042, Germany
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Local Institution - 0038 Buxtehude Niedersachsen, 21614, Germany
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Local Institution - 0137 Ludwigshafen A. Rhein Rheinland-Pfalz, 67063, Germany
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Local Institution - 0003 Luebeck Schleswig-Holstein, 23538, Germany
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Local Institution - 0136 Dortmund , 44137, Germany
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Local Institution - 0166 Frankfurt , 60590, Germany
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Local Institution - 0135 Goettingen , 37075, Germany
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Local Institution - 0138 Hamburg , 20251, Germany
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Local Institution - 0148 Koeln , 50937, Germany
Local Institution - 0165 Marburg , 35043, Germany
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Local Institution - 0081 Tuebingen , 72076, Germany
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Local Institution - 0026 Afula North, 18341, Israel
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Local Institution - 0054 Jerusalem , 91120, Israel
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Local Institution - 0170 Milano Milan, 20133, Italy
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Local Institution - 0051 Bari , 70124, Italy
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Local Institution - 0077 Genova , 16132, Italy
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Local Institution - 0084 Napoli , 80131, Italy
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Local Institution - 0104 Monterrey Nuevo Leon, 64460, Mexico
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Local Institution - 0131 Puebla , 72424, Mexico
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Local Institution - 0158 Lørenskog Kristiansand, 1478, Norway
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Local Institution - 0163 Bodo , 8092, Norway
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Local Institution - 0156 Kalnes , 1714, Norway
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Local Institution - 0155 Oslo , 0379, Norway
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Local Institution - 0171 Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
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Local Institution - 0005 Opole Opolskie, 45-06, Poland
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Local Institution - 0021 Krakow , 30-51, Poland
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Local Institution - 0086 A Coruna A Coruña, 15006, Spain
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Local Institution - 0012 Donostia Gipuzkoa, 20014, Spain
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Local Institution - 0134 Badalona , 08916, Spain
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Local Institution - 0126 Madrid , 28009, Spain
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Local Institution - 0151 Valencia , 46014, Spain
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Local Institution - 0062 Solna Stockholm, 171 6, Sweden
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Local Institution - 0157 Linkoeping Vastergotland, 58185, Sweden
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Local Institution - 0069 Uppsala , 751 8, Sweden
Local Institution - 0120 Newcastle upon Tyne Northumberland, NE7 7, United Kingdom
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